1. ELIGIBILITY CRITERIA- Summarised
A randomised phase III trial comparing radical hysterectomy and pelvic node dissection vs simple hysterectomy
and pelvic node dissection in patients with low-risk early-stage cervical cancer
TRIAL DESIGN
SAMPLE SIZE
RATIONALE
700 patients internationally
Predicted recruitment time = 3 1/2 years
Randomisation
As a result of effective screening in developed countries, the proportion of younger women presenting with low-risk early-stage disease has increased. Surgical therapy is highly efficacious in providing durable disease control in these patients, however they are at risk of suffering “survivorship” issues related to long-term surgical effects, including compromised sexual, bowel and bladder function, as well as infertility.
ELIGIBILITY CRITERIA- Summarised
INCLUSION:
Histological confirmed adenocarcinoma, squamous or adenosquamous cancer of the cervix
FIGO Stage 1A2 or 1B1
Physical examination, recto-vaginal examination and visualization of the cervix by speculum or colposcopic examination have been done after initial diagnostic procedure and prior to randomisation.
Chest X-Ray or CT scan of chest AND pelvic MRI (pelvic MRI is optional if the patient has stage IA2 disease and underwent a LEEP or cone)
Suitable for surgery
No desire to preserve fertility
Willing to complete the Quality of Life Questionnaire
Written informed consent
Able to comply with protocol treatment and follow up
Surgery to be completed within 20 weeks of initial diagnosis
≥18 years of age
EXCLUSION:
Patients with FIGO IA1 disease
History of other malignancies (see protocol for exceptions)
Evidence of lymph node metastasis
Patients who have had or will receive neoadjuvant chemotherapy
Patients who are pregnant
Control Arm
Radical Hysterectomy with pelvic node dissection
+/- Sentinel node mapping*
Experimental Arm
Simple Hysterectomy with pelvic node dissection
+/- Sentinel node mapping*
PRIMARY ENDPOINT
Pelvic relapse-free survival
SECONDARY ENDPOINTS
To compare the two treatment arms with respect to:
Extrapelvic relapse-free survival
Relapse-free survival (any site)
Overall survival
Treatment-related adverse events
Patient-reported outcomes including global quality of life and measures of sexual health
Cost-effectiveness and cost-utility
To observe rates of the following in this patient population: sentinel node detection, parametrial involvement, involvement of surgical margins, pelvic node involvement
Protocol mandated follow up
* Regardless of treatment assignment, surgery will include pelvic lymph node dissection with optional sentinel lymph node (SN) mapping. If SN mapping is to be done, the mode is optional, but the laparoscopic approach is preferred.
Trial Contact:
UK Lead Investigator: Professor John Tidy
Sponsor: NCIC Clinical Trials Group (Canada)
UK Coordination: CRUK & UCL Cancer Trials Centre
DURATION OF PATIENT FOLLOW UP
Following surgery, patients will be seen:
3-monthly in year one
4-monthly in year two
6-monthly in year three
Annually thereafter until study closure
SHAPE Summary v2.0 dated